GB2606135A - Lateral flow test apparatus - Google Patents

Lateral flow test apparatus Download PDF

Info

Publication number
GB2606135A
GB2606135A GB2104453.2A GB202104453A GB2606135A GB 2606135 A GB2606135 A GB 2606135A GB 202104453 A GB202104453 A GB 202104453A GB 2606135 A GB2606135 A GB 2606135A
Authority
GB
United Kingdom
Prior art keywords
housing
capillary tube
test strip
receiving region
sample
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
GB2104453.2A
Other versions
GB202104453D0 (en
Inventor
David Farmer Matthew
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Owen Mumford Ltd
Original Assignee
Owen Mumford Ltd
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Owen Mumford Ltd filed Critical Owen Mumford Ltd
Priority to GB2104453.2A priority Critical patent/GB2606135A/en
Publication of GB202104453D0 publication Critical patent/GB202104453D0/en
Priority to US17/679,271 priority patent/US20220308051A1/en
Priority to CN202210315193.4A priority patent/CN115144573A/en
Publication of GB2606135A publication Critical patent/GB2606135A/en
Pending legal-status Critical Current

Links

Classifications

    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B01L3/5023—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures with a sample being transported to, and subsequently stored in an absorbent for analysis
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/543—Immunoassay; Biospecific binding assay; Materials therefor with an insoluble carrier for immobilising immunochemicals
    • G01N33/54366—Apparatus specially adapted for solid-phase testing
    • G01N33/54386—Analytical elements
    • G01N33/54387—Immunochromatographic test strips
    • G01N33/54388—Immunochromatographic test strips based on lateral flow
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/483—Physical analysis of biological material
    • G01N33/487—Physical analysis of biological material of liquid biological material
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L3/00—Containers or dishes for laboratory use, e.g. laboratory glassware; Droppers
    • B01L3/50—Containers for the purpose of retaining a material to be analysed, e.g. test tubes
    • B01L3/502—Containers for the purpose of retaining a material to be analysed, e.g. test tubes with fluid transport, e.g. in multi-compartment structures
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/06—Auxiliary integrated devices, integrated components
    • B01L2300/069—Absorbents; Gels to retain a fluid
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/08—Geometry, shape and general structure
    • B01L2300/0809—Geometry, shape and general structure rectangular shaped
    • B01L2300/0825—Test strips
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2300/00—Additional constructional details
    • B01L2300/08—Geometry, shape and general structure
    • B01L2300/0832—Geometry, shape and general structure cylindrical, tube shaped
    • B01L2300/0838—Capillaries
    • B—PERFORMING OPERATIONS; TRANSPORTING
    • B01—PHYSICAL OR CHEMICAL PROCESSES OR APPARATUS IN GENERAL
    • B01L—CHEMICAL OR PHYSICAL LABORATORY APPARATUS FOR GENERAL USE
    • B01L2400/00—Moving or stopping fluids
    • B01L2400/04—Moving fluids with specific forces or mechanical means
    • B01L2400/0403—Moving fluids with specific forces or mechanical means specific forces
    • B01L2400/0406—Moving fluids with specific forces or mechanical means specific forces capillary forces

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Immunology (AREA)
  • Hematology (AREA)
  • Engineering & Computer Science (AREA)
  • Analytical Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Biomedical Technology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Clinical Laboratory Science (AREA)
  • Urology & Nephrology (AREA)
  • Molecular Biology (AREA)
  • Physics & Mathematics (AREA)
  • General Physics & Mathematics (AREA)
  • Biochemistry (AREA)
  • Medicinal Chemistry (AREA)
  • Pathology (AREA)
  • Food Science & Technology (AREA)
  • Biotechnology (AREA)
  • Cell Biology (AREA)
  • Microbiology (AREA)
  • Biophysics (AREA)
  • Investigating Or Analysing Biological Materials (AREA)

Abstract

A lateral flow test apparatus comprising a housing 2, a test strip 5 located within the housing, a capillary tube 10 having first and second ends with the first end 18a configured to receive a fluid sample to be tested and the second opposed end 18b, the housing and the test strip define an air gap 16 between the second end and a fluid sample receiving region of the test strip, and a user actuable mechanism 4 configured to move the receiving region across the air gap and into contact with the capillary second end, whereby, in use, a sample fluid within the capillary tube is drawn from the capillary tube into the receiving region of the test strip. Ideally, the user actuable mechanism is a button which extends through the housing and is movable to push the receiving region of the test strip into contact with the second end of the capillary tube. Alternatively, the mechanism may comprise a ramp providing a cam surface.

Description

LATERAL FLOW TEST APPARATUS
Technical Field
The present invention relates to lateral flow test apparatus and in particular, though not necessarily, so such apparatus that are used to test a biological sample such as a human biological sample.
Background
Lateral flow test apparatus or devices are typically relatively simple devices intended to detect the presence of a target substance in a liquid sample without the need for specialized and costly equipment. These tests are widely used in medical diagnostics for home testing, point of care testing, or laboratory use. For instance, the home pregnancy test is a lateral flow test that detects a certain hormone. These tests are simple, economic and generally show results in around five to 30 minutes. Lateral flow tests devices have also been hugely important in the response to the ongoing Covid-19 pandemic. Biological samples commonly tested by lateral flow test devices include blood, saliva, and sputum.
In many lateral flow test devices, the amount of sample fluid applied to the test strip can be critical.
Either too much fluid or too little fluid can give rise to an erroneous result. This can be problematic where a capillary tube or passage is fixed to the device and is used to draw the sample fluid from a source, such as a blood droplet on a user's finger, onto an end of the test strip (typically provided with an absorbent pad). It is in this case extremely difficult to have the user withdraw his or her finger at the point where the volume of fluid drawn is just right. To address this problem it is known to use a detached capillary tube which is first applied to the source of sample fluid until filled, and then moved into contact with the pad of the test strip. This however requires the tube to be provided as a separate component or at least as a component that is movable relative to the rest of the device.
Summary
According to a first aspect of the present invention there is provided a lateral flow test apparatus comprising a housing and a test strip located within the housing. The apparatus further comprises a capillary tube having first and second ends, the first end configured to receive a fluid sample to be tested, and the second opposed end, the housing and the test strip defining an air gap between said second end and a fluid sample receiving region of said test strip, and a user actuable mechanism configured to move said receiving region across said air gap and into contact with said second end, whereby, in use, a sample fluid within said capillary tube is drawn from the capillary tube into said receiving region.
The capillary tube may be molded integrally with said housing or with a housing part making up the housing. The capillary tube may have an opening running along the whole or a part of the tube. The second end of the capillary tube may open into an enlarged opening defined by the housing or a housing part.
The test strip may comprise a porous wicking strip and a porous sample pad in contact with the porous wicking strip, said sample receiving region being a region of said porous sample pad.
The user actuable mechanism may comprise a button extending through said housing or a housing part and moveable between a first pre-use state and a second activated state, whereby movement of the button from the first to the second state causes movement of said receiving region across said air gap and into contact with said second end.
The button and housing may define two snap fit positions providing said first and second states.
The housing may comprise upper and lower housing parts between which said test strip is located.
The user actuable mechanism may comprise a button, slider or lever coupled to a ramp or other means providing a cam surface.
According to a second aspect of the present invention there is provided a lateral flow test apparatus comprising a housing configured to receive a test strip. The apparatus further comprises a capillary tube having first and second ends, the first end configured to receive a fluid sample to be tested, and the second opposed end, the housing and the test strip, when installed, defining an air gap between said second end and a fluid sample receiving region of said test strip, and a user actuable mechanism configured to move said receiving region across said air gap and into contact with said second end, whereby, in use, a sample fluid within said capillary tube is drawn from the capillary tube into said receiving region.
Brief Description of the Drawings
Figure 1 shows a lateral flow test device in (a) upper plan view, (b) side view, and (c) lower plan view; Figure 2 is an exploded perspective view of the device of Figure 1; Figures 3(a) to (d) illustrate steps in performing a test using the device of Figures 1 and 2; and Figures 4(a) to (g) illustrate exemplary lateral flow test devices.
Detailed Description
As has been noted above, lateral flow test apparatus or devices provide a very simple and relatively cheap way of performing various tests on a sample of biological fluid ("sample"). It is desirable however to integrate into the devices a means to control, relatively precisely, the volume of sample offered up to the test strip. Any such means should be as simple as possible.
Figure 1 illustrates an exemplary lateral flow test device 1, where view (a) is a top plan view of the device, (b) is a side view, and (c) is a bottom plan view. The device 1 is extremely simple in its construction as is best shown in the exploded perspective view of Figure 2. The device comprises three principle injection molded plastic components including: an upper housing part 2 and a lower housing part 3 which together define a device housing 17, and a transfer button 4. A lateral flow test strip 5 is sandwiched between the upper and lower housing parts such that it is gripped by features of these parts when the parts are secured together, e.g. via a snap-fit arrangement. The lateral flow test strip 5 will not be described here in detail as it may be of known construction. It is sufficient to note that it comprises a porous wicking strip 6 on which are located indicator "lines" 7 of reactive molecules (four such lines are shown in the Figures) configured to perform the test or tests of interest, and a porous sample pad 8 located at one end of the strip.
The upper housing part 2 defines a substantially rectangular opening or window 9 through which the indicator lines 7 are visible. Markers are provided on the upper housing part, adjacent the window, to identify the lines (in this case "G", "M", "A" and "C"). The upper housing part further defines a capillary tube 10 that is open along its upper surface and at both ends, 18a, 18b. The tube, which may be molded integrally with the upper housing part, opens at one end into a generally circular flow through opening 11 formed in the upper housing part. The device is configured such that the opening 11 is located directly above the sample pad 8. It will be noted that the flow through opening 11 extends around the end 18b of the capillary tube such that a space beneath the tube, within the housing, is visible.
The transfer button 4 is located within a generally circular lower opening 12 formed in the lower housing part 3. As will be clear from the following discussion concerning Figures 3(a) to (d), the button comprises a button head 13 at its lower end and, extending upwardly therefrom, a generally cylindrical split pin. A pair of circular barbs 15a,b extend around the outer surface of the split pin.
During assembly, the button is engaged with the lower housing part by pressing the button into the lower opening 12 such that the uppermost barb 15a engages with the periphery of the lower opening. The axial spacing between the upper and lower barbs is such that, in this configuration, the button is securely retained within the lower opening. Furthermore, in this pre-use configuration, the test strip substantially rests on the upper end of the button such that the upper surface 16 of the sample pad 8 is spaced apart from the lowermost surface of the flow through opening 11. NB. The test strip 5 is clamped (to at least some extent) at both ends between the two housing parts such that the upper surface 16 of the sample pad 8 does not move to any significant extend in its pre-use state.
Use of the device 1 will now be described with reference to the cross-sectional views of Figures 3(a) to (d), which show a detail of the end of the device at which the capillary tube 10 and button 4 are provided, where Figure 3(a) shows a pre-use state. To perform a test (assuming that the sample is a blood sample), a user first pricks his or her finger with a needle or lancet. Such a needle or lancet may be provided as a separate component or may be integrated into the device.
This will cause a spot of blood to form on the skin. The user brings the droplet 19 into contact with the exposed end of the capillary tube 10 as shown in Figure 3(b), causing blood 20 to be drawn from the drop into the tube. Blood is drawn into the tube until the tube is completely filled, as shown in Figure 3(c). Blood does not flow out of the lower end of the tube as that end is exposed only to air. The user then withdraws his or her finger leaving a precisely defined volume of blood in the tube. It will be noted that the opening along the upper surface of the capillary tube 10 provides a visual indication to the user that the tube is being filled. This could otherwise be achieved by making the tube of a transparent material.
The next step in the procedure is for the user to fully depress the button 4 into the lower housing part 2. This causes the lowermost barb 15b to snap into the lower opening 12. Again, the dimensions of the button and opening, including the thickness of the lower housing part, are such that the button is retained in the depressed position with little or no freedom to move. As can be seen in Figure 3(d), fully depressing the button 4 forces the end of the test strip 5, including the sample pad 8, to move upwards, bringing the pad into contact with the periphery of the flow through opening 11 and with the blood at the lower end of the capillary tube 10. At this stage, blood is absorbed into the pad from the capillary tube until the tube is substantially emptied. It will be appreciated that, assuming that the pad 8 is of a light or otherwise contrasting colour, the user will observe a visible red spot form on the pad through the opening. This gives visual feedback to the user that the button has been pressed and the test is in progress.
The presented sample may then flow along the porous wicking strip 6 with appropriate, visible, reactions occurring at the lines 7. A buffer or other transport fluid may need to be inserted through the flow through opening 11, e.g. by squeezing drops out of a bottle or vial, to cause the sample to be moved along the strip 6. In some cases, a vial of transport fluid may be integrated into the device with means for releasing the fluid above or otherwise into the pad 8.
Figures 3(a) to (g) illustrate various exemplary embodiments of a lateral flow test device as follows: (a) Use of a button provided in the lower housing part as described above with reference to Figures 1 and 2.
(b) Use of a lever mounted with the upper housing part, such that movement of the lever from a first to a second position presses the end of the capillary tube downwards onto the sample pad.
(C) A side lever is mounted within the lower housing part. This might present a cam surface against the underside of the test strip which presses the strip and pad upwards as the lever is moved.
(d) A button is mounted within the lower housing part and presents a ramp to the underside of the test strip.
(e) A slider is provided in the upper housing part at an end opposed to the flow through opening. Movement of the slider causes a ramp to move under the tests strip and push it upwards.
It will be appreciated by the skilled person that various modifications may be made to the above described embodiments without departing from the scope of the present invention. For example, whilst the capillary tubed is described above as being open along its upper extent, the tube may alternatively be closed.

Claims (10)

  1. Claims 1. A lateral flow test apparatus comprising a housing and a test strip located within the housing, the apparatus further comprising: a capillary tube having first and second ends, the first end configured to receive a fluid sample to be tested, and the second opposed end, the housing and the test strip defining an air gap between said second end and a fluid sample receiving region of said test strip: and a user actuable mechanism configured to move said receiving region across said air gap and into contact with said second end, whereby, in use, a sample fluid within said capillary tube is drawn from the capillary tube into said receiving region.
  2. 2. Apparatus according to claim 1, wherein said capillary tube is molded integrally with said housing or with a housing part making up the housing.
  3. 3. Apparatus according to claim 1 or 2, wherein said capillary tube has an opening running along the whole or a part of the tube.
  4. 4. Apparatus according to any one of the preceding claims, wherein said second end of the capillary tube opens into an enlarged opening defined by the housing or a housing part.
  5. 5. Apparatus according to any one of the preceding claims, wherein said test strip comprises a porous wicking strip and a porous sample pad in contact with the porous wicking strip, said sample receiving region being a region of said porous sample pad.
  6. 6. Apparatus according to any one of the preceding claims, wherein said user actuable mechanism comprises a button extending through said housing or a housing part and moveable between a first pre-use state and a second activated state, whereby movement of the button from the first to the second state causes movement of said receiving region across said air gap and into contact with said second end.
  7. 7. Apparatus according to claim 6, wherein said button and housing define two snap fit positions providing said first and second states.
  8. 8. Apparatus according to any one of the preceding claims, wherein said housing comprises upper and lower housing parts between which said test strip is located.
  9. 9. Apparatus according to any one of claims 1 to 5, wherein said user actuable mechanism comprises a button, slider or lever coupled to a ramp or other means providing a cam surface.
  10. 10. A lateral flow test apparatus comprising a housing configured to receive a test strip, the apparatus further comprising: a capillary tube having first and second ends, the first end configured to receive a fluid sample to be tested, and the second opposed end, the housing and the test strip, when installed, defining an air gap between said second end and a fluid sample receiving region of said test strip; and a user actuable mechanism configured to move said receiving region across said air gap and into contact with said second end, whereby, in use, a sample fluid within said capillary tube is drawn from the capillary tube into said receiving region.
GB2104453.2A 2021-03-29 2021-03-29 Lateral flow test apparatus Pending GB2606135A (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
GB2104453.2A GB2606135A (en) 2021-03-29 2021-03-29 Lateral flow test apparatus
US17/679,271 US20220308051A1 (en) 2021-03-29 2022-02-24 Lateral flow test apparatus
CN202210315193.4A CN115144573A (en) 2021-03-29 2022-03-28 Lateral flow test equipment

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
GB2104453.2A GB2606135A (en) 2021-03-29 2021-03-29 Lateral flow test apparatus

Publications (2)

Publication Number Publication Date
GB202104453D0 GB202104453D0 (en) 2021-05-12
GB2606135A true GB2606135A (en) 2022-11-02

Family

ID=75783796

Family Applications (1)

Application Number Title Priority Date Filing Date
GB2104453.2A Pending GB2606135A (en) 2021-03-29 2021-03-29 Lateral flow test apparatus

Country Status (3)

Country Link
US (1) US20220308051A1 (en)
CN (1) CN115144573A (en)
GB (1) GB2606135A (en)

Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20190317115A1 (en) * 2018-04-11 2019-10-17 Vitameter Inc. Integrated point-of-care cartridge assay system
US20200345286A1 (en) * 2019-05-03 2020-11-05 Orangelife Comércio E Indústria Ltda - Me Cassette device for quick test of diagnosis, method for detecting a ligand in a biological sample and kit
WO2020260250A1 (en) * 2019-06-25 2020-12-30 University Of Ulster Lateral flow immunoassay device
US20210178389A1 (en) * 2019-12-11 2021-06-17 Magnolia Medical Technologies, Inc. Fluid transfer devices with integrated flow-based assay and methods of using the same

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8012770B2 (en) * 2009-07-31 2011-09-06 Invisible Sentinel, Inc. Device for detection of antigens and uses thereof
EP2777499B1 (en) * 2013-03-15 2015-09-16 Ortho-Clinical Diagnostics Inc Rotatable fluid sample collection device

Patent Citations (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20190317115A1 (en) * 2018-04-11 2019-10-17 Vitameter Inc. Integrated point-of-care cartridge assay system
US20200345286A1 (en) * 2019-05-03 2020-11-05 Orangelife Comércio E Indústria Ltda - Me Cassette device for quick test of diagnosis, method for detecting a ligand in a biological sample and kit
WO2020260250A1 (en) * 2019-06-25 2020-12-30 University Of Ulster Lateral flow immunoassay device
US20210178389A1 (en) * 2019-12-11 2021-06-17 Magnolia Medical Technologies, Inc. Fluid transfer devices with integrated flow-based assay and methods of using the same

Also Published As

Publication number Publication date
US20220308051A1 (en) 2022-09-29
CN115144573A (en) 2022-10-04
GB202104453D0 (en) 2021-05-12

Similar Documents

Publication Publication Date Title
KR100662124B1 (en) Sample testing device
WO2018188458A1 (en) Sample collector, and sample collection and detection device and method
US7225689B2 (en) Sample testing device with funnel collector
US11358139B2 (en) Pinch to open sample collection device
CA2624971C (en) Device for detecting analytes in fluid samples
US7591791B2 (en) Diagnostic thimble
CA2909263C (en) Biological fluid sampling transfer device and biological fluid separation and testing system
US20020052618A1 (en) Analytical device with integrated lancet
EP0188497A1 (en) Apparatus for sampling a fluid
US20190320960A1 (en) Blood collection device with integrated absorbent material
CN101288592A (en) Analytical system for detecting an analyte in a body fluid and disposable integrated puncturing and analyzing element
CA3155849C (en) Sample collection and detection device and method
JP2000254111A (en) Device for measuring body fluid component
JP3898399B2 (en) Assembly including lancet and body fluid component detection unit
US20220308051A1 (en) Lateral flow test apparatus
JP2024537926A (en) Urine test kit
CN110462366B (en) Apparatus for concentrating biological samples prior to immunoassay
JP2001021556A (en) Body fluid component measuring instrument